Status:
TERMINATED
Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease
Lead Sponsor:
Bioinova, s.r.o.
Collaborating Sponsors:
University Hospital, Motol
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
Subjects in whom a posterolateral fusion surgery has been planned and who meet the inclusion and exclusion criteria were proposed to receive a single-dose AMSC treatment, in order to assess its safety...
Detailed Description
Following informed consent collection at the screening visit and verification of all inclusion and exclusion criteria, eligible patients will undergo the procedure of bone marrow cell aspiration from ...
Eligibility Criteria
Inclusion
- established diagnosis of spinal degenerative disease indicated for lumbar spine surgery,
- patients indicated for fusion therapy,
- patients between 18-55 years, both sexes,
- patients able to provide written informed consent.
Exclusion
- previous lumbar spine surgery in the same segment of the spine, in order to achieve vertebral fusion,
- osteoporosis,
- diabetes mellitus,
- pregnancy or breastfeeding,
- women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contraceptive measures taken by their sexual partners,
- fertile men not using proven contraceptive measures including effective contraception method in their partner (established oral contraception, intrauterine device, ligation of the uterine tube),
- coagulopathy,
- malnutrition, primary biliary cirrhosis,
- skin infection at the site of bone marrow aspiration or at the site of spinal fusion,
- gastrostomy,
- any significant medical condition that would compromise the safety of the patient (e.g. recent myocardial infarction, congestive heart failure, renal failure, liver failure, systemic infection, recurrent thromboembolic disease .....),
- alcohol or drug abuse,
- cancer (compulsory clinical oncological screening),
- ongoing or recent (last 3 months) systemic corticosteroid or immunosuppressive therapy.
Key Trial Info
Start Date :
August 27 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03827096
Start Date
August 27 2013
End Date
December 14 2016
Last Update
January 18 2020
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